Risk-Based Clinical Quality Assurance


Risk-Based Clinical Quality Assurance:
Train Your Auditors Like the FDA Does

Bethesda, MD • June 18-19, 2014




8:00 a.m. – 8:30 a.m.

Registration and Continental Breakfast

8:30 a.m. – 10:00 a.m.

Starting on the Same Page: Good Clinical Practice Regulatory Requirements and Expectations

  • Review of FDA and GCP requirements for conducting a clinical study
  • What role does ICH have in good clinical practices?
  • Responsibilities associated with institutional review boards and ethic committees (IRB/EC)
  • Principal investigator roles and responsibilities
  • Essential elements of informed consent agreement
  • What is the sponsor’s role in the clinical study
  • Understanding the study protocol
  • The investigator’s brochure — why is it important?

10:00 a.m. – 10:15 a.m.


10:15 a.m. – 12:00 p.m.

GCP Audits: What Audits Are Needed to Maintain a Compliant GCP Program

  • What are the fundamentals of a GCP audit?
  • Establishing an audit program
  • The components of an audit program
  • Qualifying a clinical research organization (CRO)
  • Central laboratory audits and why they need to be a component of a GCP program
  • Auditing clinical sites — who gets the audit and why?
  • Why is it important to address the audit observations and follow-up?

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 3:00 p.m.

Working With a CRO: Conducting Compliant GCP Studies

  • When utilizing the services of a CRO, it is still important to meet and maintain the sponsor’s requirements
  • When working with a clinical site: Are GCPs being followed and most importantly, are they being documented?
  • The “relationships”: QA, clinical and the CRO — a tenuous relationship at best
  • The audit: aspects and specifics — what is the value of an audit?
  • Audit follow-up — always important to conduct the audit but are the recommendations and corrections implemented?
  • Post-CRO assessment — was the relationship with the sponsor and the CRO successful? — A checklist to evaluate the performance

3:00 p.m. – 3:15 p.m.


3:15 p.m. – 5:00 p.m

Most Commonly Cited GCP Violations at a Clinical Site

  • Principles of GCPs at a clinical site
  • The areas FDA investigators focus on
  • PI responsibilities for the study — why the sponsor and the PI sometimes differ in this area
  • Reviewing FDA inspections and the top five GCP violations

5:00 p.m.

Session Wrap-Up, End of Day 1


8:00 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:30 a.m.

Writing GCP Audit SOPs: Elements of the SOPs

  • INTERACTIVE EXERCISE! Writing a clinical site audit SOP; why do you need this SOP; what are the important elements of this SOP?
  • INTERACTIVE EXERCISE! Writing a central laboratory audit SOP; why do you need this SOP; what are the important elements of this SOP?

10:30 a.m. – 10:45 a.m.


10:45 a.m. – 12:00 p.m.

Preparing And Setting Up CQA Audits

  • Selecting sites to be audited — creating a master audit plan and how to make sure it is met
  • Auditing contract research organizations (CRO) — why is it important to audit a phase 1 unit
  • Audits of a central laboratory — why lab data and testing are a critical component of the clinical study
  • Managing the audits (logistics, time, etc) — why managing the logistics of an audit are critical to the audit itself
  • Conducting the audits — what makes a “good” auditor?
  • The site visit audit report — when and how the report is a valuable tool
  • Evaluating the audit findings and implementing corrective actions — whose responsibility is it?

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 5:00 p.m.

5 Tools For CQA Auditors

  • Preparing for the audit: A checklist does not make you a good auditor but it is a useful tool
  • The auditor’s performance: how to be nice but still maintain professional efficiency
  • Interviewing skills
  • INTERACTIVE EXERCISE! Interviewing a peer
  • Writing skills: report formats most auditors find useful
  • INTERACTIVE EXERCISE! Creating a report format
  • Postassessment of the study: was it successful and did the “relationships” (clinical, quality and the CRO) work?

5:00 p.m.

Workshop Adjourns